Artificial sphincter

ABSTRACT

An artificial sphincter including a U-shaped resilient clamp adapted to normally engage and close a urethra, a piston-cylinder device located between the ends of the clamp, and a fluid-filled flexible container connected by a tube to the piston-cylinder device so that when the container is compressed the pistoncylinder device drives the clamp to an open position which permits urine to flow through the urethra. The clamp supports a screw which extends, by an adjustable amount, into the cylinder of the device and serves as a stop for the piston. The stop determines the minimum distance between the ends of the U-shaped clamp and, therefore, the maximum pressure exerted by the clamp against a urethra. Further, the clamp includes tabs by which it may be surgically connected to the posterior side of a pubic bone and the container includes tabs by which it may be surgically connected to the anterior side of the pubic bone, so that the entire sphincter is located within the body. With this arrangement, the container may be compressed against the pubic bone from outside the body to open the urethra. Preferably, exposed surfaces of the clamp and container are covered by a protective silicone material.

United States Balaban atent I [1 1 [451 June 11, 1974 1 i ARTIFICIAL SPHINCTER [76] Inventor: Donald Roy Balahan, 618

Clearwood Dr., Richardson, Tex. 75080 [22] Filed: Jan. 26, 1973 21 Appl. No.: 326,636

[52] U.S. CI 128/1 R, 128/346, 3/1, l28/DIG. 25 [51] Int. Cl ..A61f1/00, A6lb 17/00 [58] Field of Search..... 128/1 R, 346, 327, DIG. 25, 128/295 [56] I References Cited UNITED STATES PATENTS 2,533,924 12/1950 .Foley 128/346 3,419,008 12/1938 Plishner 128/346 3,744,063 7/1973 McWhorter 3/1 FOREIGN PATENTS ORAPPLICATIONS 1,174,814 12/1969 Great Britain 128/DIG. 25

OTHER PUBLICATIONS G. Timm et al., ElectroMechanical Restoration of the Micturition Reflex, IEEE Transactions on Bio- Medical Engineering, .1 uly 1 97 1,

Primary Examiner-Aldrich F Medbery Attorney, Agent, or FirmBreitenfeld & Levine [57] ABSTRACT An artificial sphincter including a U-shaped resilient clamp adapted to normally engage and close a we thra, a piston-cylinder device located between the v ends of the clamp, and a fluid-filled flexible container connected by a tube to the piston-cylinder device so that when the container is compressed the pistoncylinder device drives the clamp to an open position which permits urine to flow through the urethra. The clamp supports a screw which extends, by an adjustable amount, into the cylinder of the device and serves as a stop for the piston. The stop determines the mini-.

mum distance between the ends of the U-shaped' clamp and, therefore, the maximum pressure exerted by the clamp against a urethra. Further, the clamp includes tabs by which it may be surgically connected to the posterior side of a pubic bone and the container includes tabs by which it may be surgically connected to the anterior side of. the pubic bone, so that the entire sphincter is located within the body. With this arrangement, the container may be compressed against the pubic bone from outside the body to open the urethra. Preferably, exposed surfaces of the clamp and container are covered by a protective silicone material.

9 Claims, 3 Drawing Figures ARTIFICIAL SPHINCTER The subject invention relates to an artificial sphincter, and in particular to a clamping device for controlling the flow of urine through a urethra.

It is known that urinary incontinence in afflicted persons may be controlled by the use of clamps which are capable of selectively opening or closing their urethras. One such device, as described in US. Pat. No. 2,455,859, consists of a clamp adapted to engage the urethral in the penile area, and a control device for the clampwhich may be carried in a clothing pocket. Another such device, described in US. Pat. No. 3,419,008, consists of a surgically implanted urethra clamp which may be controlled from outside the body with a magnet. Because the control device of the above mentioned clamps are carried outside of the body-they are subject to accidental damage or loss. As a result, wearers of such devices are frequently inconvenienced.

Accordingly, it is an object of the present invention to provide an artificial sphincter or clamping device which can be completely implanted within the body of a person suffering from urinary incontinence.

I It is another object of the present invention to provide a urethral clamping device which is relatively easy to apply, simple to control, highly compact, rugged, and reliable. g

It is still another object of the invention to provide an artificial sphincter which is attachable to a pubic bone for controlling the flow of urine through the urethra of a person suffering from urinary incontinence.

By way of summary, an artificial sphincter for controlling the flow of urine through the urethra of a person suffering from urinary incontinence includes: a resilient clamp which normally closes the urethra so as to prevent the flow of urine therethrough, means for mounting the clamp to the posterior side of the pubic bone, a cylinder coupled to one end of the clamp, a piston slidable within the cylinder and coupled to the other end of the clamp, a flexible fluid container, means for mounting the container to the anterior side of the pubic bone, and a tube coupling the fluid in the container to the cylinder. With this arrangement, when the container is compressed, by applying pressure to the persons abdomen, the piston is actuated by the fluid and opens the clamp to permit the flow of urine through the urethra. Upon release of the pressure, the clamp returns to its normal position closing the urethra.

The above-mentioned and other objects of this invention will become apparent by reference to the following description and the accompanying drawings, in which:

FIG. 1 is a perspective view of an artificial sphincter, according to the invention;

FIG. 2 is a cross-sectional view of the clamp portion of the artificial sphincter, the clamp being shown engaged with a urethra in a closed and open position (dotted line); and

HG. 3 is a horizontal cross-sectional view of human body showing the artificial sphincter connected to the pubic bone in the body.

An artificial sphincter 10, according to the invention, is shown in FIG. 1. Generally, the artificial sphincter includes a resilient urethral clamp 11, a piston-cylinder device 12 for opening the clamp 11; and a resilient fluid filled container 13 for controlling, via the flexible tube 14, the device 12. Operatively, when the flexible container 13 is compressed, fluid pressure is built up in the cylinder of device 12 and the ends of the clamp are, thereby, spread apart. Thereaften when the pressure is removed from the cylinder, the inherent resilience of the clamp restores the clamp to its initial position.

More particularly, the resilient container '13 of the present example has a semi-circular cross-sectional shape, and may be formed of any suitable material which after being compressed springs back to its original shape. The container is filled with a gas which will not harm the body, and includes a hole (not shown) to which an end of the tube 14 is attached so that the interior of the container 13 communicates with the hollow interior of the tube 14. A relatively stiff rectangular plate 16 forms the base of container 13, and carries a plurality of tabs 18 by which the container may be surgically attached, e.g., sutured, to the periosteum covering an anterior section of the pubic bone 17. Each tab may be thin enough to be pierced by a suturing needle, or each-tab may be formed with a hole. To prevent deterioration of the container 13 and reaction with internal body fluids and parts, the container may be coated, for example, with a material 19 containing organosilicon polymers, such as is sold under the brand name Silastic by the Dow Corning Corp.

Referring to FIG. 2, urethral. clamp 11 includes, for example, a U-shaped element 21 which may be formed of spring steel, having'a hole 22 near the free end of one of its straight sections 23, a hole 24 near the free end of the other of its straight sections 25, and a threaded hole 26 in section 25. Holes 24 and 26 communicate with the interior of a cylinder 27, which forms part of the piston-cylinder device 12, the cylinder being secured to section 25 and extending toward section 23. The bent section of element 21 constitutes resilient means biasing sections 23 and 25 toward each other.

The cylinder 27 includes a hole 28 aligned with hole 22. Slidably supported within cylinder 27 is a piston 29 having a stem30 extending towards section 23 and slidably engaging the hole 28. Stem 30 includes a flange 31 and a thread 32 running from the flange 31 to its end. In addition, the threaded end of stem 30 passes through the hole 22 in section 23, and the engagement of the thread 32 by a nut 33 serves to couple the stem to the section 23. Thus, when the piston 29 moves with respect to the cylinder the sections 23 and 25 of the clamp 21 follow the motion.-

Threaded hole 26 supports a threaded screw 34 whose end is located within a region 36 of the cylinder. Thus, the amount of penetration of the end of screw 34 can be controlled by rotation of the screw 34. The end of the screw 34 is adapted to engage surface 37 of piston 39 and hence serves as an abutment or stop for the piston 29 and, thus, limits the minimum spacing between the sections 23 and 25. As more fully described below, the minimum spacing determines the maximum pressure which will be exerted by the clamp 11 on the urethra 35. The end 38 of the tube 14, opposite the end secured to container 13, is attached to the region 36 of cylinder 27. Thus, when the container 13 is depressed, the fluid within it, e.g.', carbon dioxide, is forced into the region 36 and the piston 29 and clamp section 25 are moved away from each other, thereby increasing the spacing between the sections 23 and 25. This increased spacing (see dotted line in FIG. 2) permits the urethra 35 to open and urine to flow through the urethra portion engaged by the sections 23 and 2 5 of the clamp. Preferably, the outside section 23 of the clamp includes a number of tabs 40, similar to tabs 18, by which the clamp may be surgically attached, e.g., sutured, to the periosteum covering a posterior section of the pubic bone 17. As with the container 13, to prevent deterioration, the clamp 21 is coated with silastic 19 or the like.

To engage the clamp with the urethra, the nut 33 is disengaged from the stem 30, the stem is withdrawn from the hole 22, the straigh't'clamp sections 23 and 25 are pulled apart, and the urethra 35 is slipped through the spacing created between the cylinder 27 and section 23 into the space between sections 23 and 25 (see FIG. 2). Thereafter, the nut 33 and stem are reengaged and the depth of penetration of screw 34 is adjusted to apply an appropriate closing pressure to the urethra 35. After the clamp has been attached to the urethra, a protective cap 43 formed, for example, of silastic is placed over the head of the screw 34, and the nut 33 and flange 31 are covered, for example, with silastic. Once thejurethra 35 and clamp ll'are properly engaged, the clamp and container are attached, as previously stated, to the pubic bone 17.

With the artificial sphincter installed as described, a wearer thereof may pass urine by pressing with his hand in on the from lower abdominal portion 45 of this body 46 which is located in front of the anterior section 16 of the pubic bone 17. This pressure compresses container 13 causing the fluid within it to flow through tube l4-into region 36 of cylinder 27 thereby spreading sections 23 and 25 of the clamp apart. When the hand pressure is released, the inherent resilience of the clamp recloses the urethra and forces the fluid out of cylinder 27 back into container 13'. Thus, only hand pressure on the body, and no external device is required to activate the artificial sphincter of this invention.

it is to be understood that the description herein of a preferredembodiment according to the invention is set forth as an example thereof and is not to be construed or interpreted as a limitation on the claims which follow and define the invention. For example, although the sphincter has been described with reference to controlling flow through the urethra, it could also be used to control flow through the rectum. Also, clamp 21 need not necessarily be resilient since the required resilience could be provided by a coil spring within cylinder 27 surrounding stem 30. The fluid within container 13 is preferably a gas, but under some circumstances a liquid may be preferred.

What is claimed is:

1. An artificial sphincter for arrangement in its' entirety within the human body, comprising;

a. a means for occluding the urethra comprising a clamp including two spaced apart sections forarrangement on opposite sides of the urethra and resilient means biasing said sections toward each other to close the urethra to prevent the flow of urine therethrough,

b. means for mounting said clamp on an internal part of the body, i

c. means to permit flow through the'urethra in response to fluid pressure applied to said clamp means, said means including a fluid-responsive means between said sections and arranged to separate the latter against the force of said resilient means,

. a fluid container,

e. means for mounting said container on an internal part of the body in a region wherein the container can be compressed by pressure applied to an exterior part of the body, and

f. a tube interconnecting said container and said fluid-responsive means for transmitting fluid between said container and fluid-responsive means,

whereby when said container is compressed by pressure applied to an exterior part of the body, fluid flow from said container to said fluid-responsive means causes said sections to separate against the force of said resilient means and permit fluid flow through the urethra, and removal of the pressure permits said resilient means to move said sections toward each other to close and prevent further flow through the urethra.

2. An artificial sphincter as defined in claim 1 wherein said means for mounting said clamp and container are tabs projecting from said clamp and container, respectively.

3. An artificial sphincter as defined in claim 1 wherein said fluid-responsive means is a piston-cylinder device.

4. An artificial sphincter as defined in claim 3 wherein said piston-cylinder device is located between said sections and arranged to move said sections apart against the resilient biasing force in response to positive fluid pressure applied to said piston-cylinder device.

5. An artificial sphincter as defined in claim 1 including adjustable abutment means for limiting the minimum spacing between said sections and hence for limiting the maximum squeezing pressure on the urethra.

6. An artificial sphincter as defined in claim 5 wherein said adjustable abutment means comprises a screw threadably engaging one of said clamp sections;

7. An artificial sphincter as defined in claim 5 wherein said fluid-responsive means is a piston-cylinder device, the cylinder of said device being secured to one of said clamp sections and the piston of said device being secured to the other of said clamp sections, and said adjustable abutment means comprises a screw threadably engaging said one clamp section and extending into said cylinder to provide an abutment for said piston.

8. An artificial sphincter as defined in claim 1 wherein the fluid in said container is a gas which is not harmful to the body.

9. An artificial sphincter as defined in claim 1 wherein said clamp is coated with a protective material which does not react with body fluids or parts. 

1. An artificial sphincter for arrangement in its entirety within the human body, comprising: a. a means for occluding the urethra comprising a clamp including two spaced apart sections for arrangement on opposite sides of the urethra and resilient means biasing said sections toward each other to close the urethra to prevent the flow of urine therethrough, b. means for mounting said clamp on an internal part of the body, c. means to permit flow through the urethra in response to fluid pressure applied to said clAmp means, said means including a fluid-responsive means between said sections and arranged to separate the latter against the force of said resilient means, d. a fluid container, e. means for mounting said container on an internal part of the body in a region wherein the container can be compressed by pressure applied to an exterior part of the body, and f. a tube interconnecting said container and said fluidresponsive means for transmitting fluid between said container and fluid-responsive means, whereby when said container is compressed by pressure applied to an exterior part of the body, fluid flow from said container to said fluid-responsive means causes said sections to separate against the force of said resilient means and permit fluid flow through the urethra, and removal of the pressure permits said resilient means to move said sections toward each other to close and prevent further flow through the urethra.
 2. An artificial sphincter as defined in claim 1 wherein said means for mounting said clamp and container are tabs projecting from said clamp and container, respectively.
 3. An artificial sphincter as defined in claim 1 wherein said fluid-responsive means is a piston-cylinder device.
 4. An artificial sphincter as defined in claim 3 wherein said piston-cylinder device is located between said sections and arranged to move said sections apart against the resilient biasing force in response to positive fluid pressure applied to said piston-cylinder device.
 5. An artificial sphincter as defined in claim 1 including adjustable abutment means for limiting the minimum spacing between said sections and hence for limiting the maximum squeezing pressure on the urethra.
 6. An artificial sphincter as defined in claim 5 wherein said adjustable abutment means comprises a screw threadably engaging one of said clamp sections.
 7. An artificial sphincter as defined in claim 5 wherein said fluid-responsive means is a piston-cylinder device, the cylinder of said device being secured to one of said clamp sections and the piston of said device being secured to the other of said clamp sections, and said adjustable abutment means comprises a screw threadably engaging said one clamp section and extending into said cylinder to provide an abutment for said piston.
 8. An artificial sphincter as defined in claim 1 wherein the fluid in said container is a gas which is not harmful to the body.
 9. An artificial sphincter as defined in claim 1 wherein said clamp is coated with a protective material which does not react with body fluids or parts. 